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    2010 35: 307 originally published online 22Science Technology Human ValuesSaul Halfon

    Confronting the WTO: Intervention Strategies in GMO Adjudication

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  • Confronting theWTO: InterventionStrategies inGMO Adjudication

    Saul Halfon1

    AbstractTheWorld Trade Organization (WTO) has been the target of social justiceactivists since its inception in 1994, with many seeking to reshape or rescindthe WTO agreements. This article instead explores possible interventionsinto WTO adjudication by compelling the reinterpretation of existingWTO documents. Such an approach can take several forms: mobilizing pro-fessional expertise, engaging technical standards, and constructing compa-nion regimes. Using the recent United States/European Communitygenetically modified organisms (GMO) case as a reference point, this articleexplores opportunities for implementing the last two strategies. The CodexAlimentarius, an international food standards regime, seems to provide aparticularly promising location for reconstructing WTO risk and govern-ance procedures. The Cartagena Biosafety Protocol, an international envi-ronmental regime, deeply challenges narrow readings of WTO texts butmay not have enough legal force in the WTO. These alternative locationsfor intervention hold promise and risks for activists seeking internationaljustice in environment, food, and trade.

    Keywordsrisk, international law, trade, harmonization, Codex Alimentarius

    1 Virginia Tech, Blacksburg, VA, USA

    Corresponding Author:

    Saul Halfon, STS Department, 232 Lane Hall (0247), Virginia Tech, Blacksburg, VA 24061.

    Email: [email protected]

    Science, Technology, & Human Values35(3) 307-329

    The Author(s) 2010Reprints and permission:

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  • Antiglobalization movements have targeted the World Trade Organization

    (WTO) and other trade agreements as particularly egregious examples of

    the universalistic, antidemocratic, corporate, elitist, and imperialist nature

    of the international system. These movements have generally sought to

    have the WTO overturned, focusing particularly on the lack of transpar-

    ency, corporate capture, and lack of meaningful environmental and labor

    standards within this body of international law, as well as the general lack

    of space or language within the WTO framework for articulating issues of

    social or economic justice.

    Dismantling such an institution, however, is often an uphill struggle, and

    many have turned instead to a strategy of modification and reconstruction.

    Some success in increased transparency is evident. For example, the WTO

    Web site is becoming a more useful and user-friendly depository of not just

    final decisions but names, procedures, and policy documents. Access to

    decision making, however, remains highly circumscribed as the WTO is

    a forum for states and not citizens, and even professional, nonstate interven-

    tions have met with much more limited success than in many other interna-

    tional institutions and forums.1

    This article explores alternative avenues of contesting and opening the

    practices of WTO decision makingapart from the movement activism

    that continues to be so important. Despite the wide perception of the

    WTO as a monolithic, closed system, it is full of tensions and contradic-

    tions that may be exploited for change. In particular, tensions within the

    WTO decision-making process itself may provide a space for other inter-

    national regimes to influence decisions. To the extent that such regimes

    are relatively more open forums for articulating the social justice con-

    cerns that motivate activists, such openings may provide useful strategies

    for intervention. This article thus suggests an important relation between

    three avenues for interventionactivism, adjudication, and negotiating

    related regimeswhile focusing primarily on the relation between the

    latter two.

    Questions of WTO accountability to national and regional values have

    been particularly acute in relation to trade in genetically modified organ-

    isms (GMOs or GM products). Controversies over GMOs animate radically

    different perceptions of risk, modernity and progress, corporate behavior,

    expertise, fair trade, environmental protection, and justice. These differ-

    ences reflect and shape quite different national regulatory and decision-

    making schemes (Jasanoff 2005) and thus conflicts over the nature and

    openness of markets. Through such conflicts between national regulatory

    cultures, GMOs have entered the purview of the WTO.

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  • A recent WTO case pitting the United States, Canada, and Argentina

    against the European Community (EC Biotech Case) has highlighted some

    of these issues and thus serves as a useful reference point throughout this

    article. This case revolves around a de facto moratorium on GM food

    approvals by the EC from 1998 until at least 2003. The major GMO pro-

    ducer nations challenged this moratorium as illegally restricting trade. In

    a decision released in September, 2006, the dispute resolution panel for the

    case ruled largely in favor of the complaining parties (WTO 2006). The out-

    come itself was hardly a surprise, but the basis of the ruling has potentially

    important implications for future WTO adjudication, while leaving many

    issues up in the air, especially since this decision has not been appealed.

    In particular, this decision has gone some way toward clarifying, though

    not completely, the relationship between theWTO and two other potentially

    relevant international regimes. The first of these, the Cartagena Biosafety

    Protocol (CBP), is an international agreement that regulates the transbound-

    ary movement of an important subclass of GMOs called living modified

    organisms (LMOs). The second, the Codex Alimentarius Commission

    (Codex), is an international food standards body that has recently produced

    standards on regulatory risk assessments for GMOs. Each of these two

    regimes has become an important site for international struggle over GMOs

    and articulates practices and norms that potentially conflict with existing

    WTO doctrine. These tensions are particularly apparent in their respective

    framing of risk and risk analysis.

    WTO, CBP, and Codex: Intersecting Institutions

    The WTO, as the central and most powerful trade institution in such dis-

    putes, provides the necessary starting point for a discussion of the relation

    between these three regimes. After mapping out the ways that the WTO has

    handled risk and GMO adjudication, therefore, I explore the potential open-

    ings and challenges provided by the other two regimes.

    WTO, GMOs, and Risk

    The WTO is the enforcement protocol and institution of the General Agree-

    ments on Tariffs and Trade (GATT), which was originally signed in 1947.

    The WTO, signed in 1994 and coming into force in 1995, modified the

    GATT itself and added a number of additional agreements, which greatly

    strengthened its purview, authority, and ability to compel state compliance.

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  • TheWTO fundamentally establishes a presumption of free trade. That is,

    outside of a set of carefully delineated exceptions, signatories to the WTO

    are expected to refrain from imposing barriers or tariffs. The WTO agree-

    ments detail the specific criteria for evaluating and understanding possible

    exceptions to the free-trade presumption. These are contained in specific

    agreements that were negotiated separately within the WTO. Even when

    allowed by an exception, regulation of international trade must be the least

    restrictive possible to meet the criteria. Three WTO agreements have par-

    ticular relevance to GMO disputes.

    The Agreement on Sanitary and Phytosanitary Measures (SPS) estab-

    lishes the basic risk framework for free-trade exceptions. This agreement

    allows countries to establish barriers to trade based on affirmative scientific

    evidence of danger to human, animal, or plant health or safety, based on

    international standards of risk assessment. Under conditions of scientific

    uncertainty, there must be a prima facie case for restrictions, on the basis

    of available pertinent information (Article 5, sec. 7).2 In general, consis-

    tency of risk standards and methods within a country and harmonization

    of methods across countries are required. This agreement has been, and is

    likely to continue to be, the central focus of dispute in WTO adjudication.

    The Agreement on Technical Barriers to Trade (TBT) disallows national

    regulations that establish a de facto trade barrier based on onerous technical

    demandssuch as quirky processing or packaging requirements. This

    agreement is also risk based, and works against country specific labeling

    standards that are not necessary to protect the public health and safety.

    So, for instance, under TBT, a requirement for labels to indicate possible

    allergens in transgenic foods would be legal, but the U.S. government has

    argued that this agreement precludes required labels designating a product

    as a GM food if this designation could not be based on an affirmed health

    risk (Wallach and Sforza 1999, 90; Swinbank 1999). Some of this concern

    has been alleviated by the EC Biotech panel which stated quite clearly that

    in the context of GMOs, required labeling is unlikely to be considered a

    technical barrier to trade since, amidst scientific uncertainty and changing

    information, labeling may have a legitimate public and environmental

    health and safety function, even without affirmative evidence of harm

    (WTO 2006, para.7.387-92).

    Finally, the Agreement on Agriculture balances a decisive move

    toward the objective of increased market orientation in agricultural trade

    with some recognition that agricultural commodities cannot be fully and

    immediately deregulated without severe negative consequences for food

    security. This agreement, therefore, allows but establishes strict limits on

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  • agricultural tariffs and subsidies. Set as flat percentages of agricultural

    production (different for developed and developing countries), tariff and

    subsidy quotas require that trade restrictions not go beyond those necessary

    for basic agricultural subsistence and security. Likewise, strict rules for

    import surge protection duties attempt to balance the free-trade presumption

    with a recognition that glutted or wildly fluctuating markets can lead to food

    insecurity (starvation or famine).

    Through these specific agreements, the WTO puts in place a decision-

    making framework that is often referred to as risk-based policy making.

    Besides the obvious implication that policy makers must consider risks, the

    risk framework stands in for a set of implicit and explicit assumptions about

    the role and nature of science, expertise, and uncertainty. The risk frame-

    work is most appropriately viewed as a heterogeneous package of concepts

    and practices, rather than a logical category, and it is thus the set of

    entailments, more than the notion of risk itself, that stands in contrast to the

    competing framework of precaution (Beck 1992; Hajer 1993;Thornton

    2000).3

    First, the WTO limits the set of risks that can be considered in restricting

    trade, allowing only those narrowly construed to pertain to the health and

    safety of humans and the environment. Health and safety refer to physical

    risks of harm of the sort that can be measured through laboratory science.

    Excluded from this assessment are most considerations of socioeconomic

    or cultural risks that may be experienced by various countries or any

    accounting for differential risk perception across communities or cultures

    (Bohanes 2002; see also Wynne 2001).4 Risk is treated as an objective and

    quantifiable property of nature that can be derived from scientific knowl-

    edge of physical laws and properties. Thus, risk-based decision making is

    inherently an expert-driven process, insulated from the vagaries of politi-

    cal or democratic input. The WTO is, in this sense, a clear example of a

    technocratic regime (for the distinction between democratic and techno-

    cratic approaches to science policy and regulation, see Dickson 1984, 219-

    20 and Jasanoff 1990, 15-6).

    Equally important to this construction of risk is the way that uncertainty

    is resolved. Uncertainty, or more accurately claims of uncertainty, often

    surrounds new products and technologies, particularly biotechnology, so

    resolving this issue is always of central concern to those involved in con-

    flicts.5 Consistent with the presumption of free trade, uncertainty on scien-

    tific risk generally provides an insufficient basis to restrict or otherwise

    regulate trade under the WTO. Article 5.7 of SPS provides a possible

    exception, stipulating that in cases where relevant scientific evidence is

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  • insufficient, SPS measures may be provisionally adopted on the basis of

    available pertinent information. The appellate panel in Japan-Apples,

    however, makes it clear that this exception only applies to insufficiency

    of scientific evidence not to scientific uncertainty or disagreement (WTO

    2003b, para.184-5). Perhaps a strange distinction to those who recognize the

    social and contextual nature of sufficiency, it nevertheless seems to

    exclude from 5.7 technologies that have been widely studied but remain

    controversial. Instead, the WTO requires affirmative scientific evidence

    of harmthat is, the restricting party bears the burden of proof for proving

    possible harm. While clearly a normative position with respect to free trade,

    this posture toward uncertainty is often naturalized as more scientific

    than precaution, thus providing legitimating force to the overall risk-

    based approach and giving rise to the sound science designation often

    used by its proponents (see Barrett and Raffensperger 1999; Levidow and

    Carr 2000; Thornton 2000, chap.11). Science is thus construed in a

    positivist sensethat is, science is understood to make only assertions

    about what is really known about the world.

    U.S. federal policy making on GM products provides some clear exam-

    ples of this risk-based approach. Relying on such a standard, U.S. agencies

    have generally ruled that bioengineered food and agricultural products are

    safe for general consumption based on their substantial equivalence to

    non-GM products.6 Regulation of recombinant bovine somatotropin (rBST)

    in 1993 is an early example of this approach. Without affirmative evidence

    of recombinant somatotropin being different than the naturally occurring

    growth hormone, the two chemicals were ruled by the US FDA to be sub-

    stantially equivalent and thus rBST was not subject to further regulation.

    Actual structural differences in the hormones were deemed insignificant

    and inconsequential, given the nonbioactivity of the natural hormone in

    humans and its complete destruction in the human gut (U.S. Government

    1994). This position was buttressed by the claim that milk produced

    naturally and through rBST treatment could not be distinguished analy-

    tically, despite the competing claim that rBST-produced milk was likely

    to contain higher quantities of the growth hormone insulin-like growth

    factor 1 (IGF-1) and antibiotic residue (due to higher rates of mastitis)

    than milk from nontreated cows. This assessment thus follows a product,

    rather than process, logic (Jasanoff 1995). In fact, any producer labels

    that implied a difference from other milk was deemed misleading and

    illegal (US FDA 2003). The effect of changing context of use, social

    impacts on farm structure, and other cultural or economic risks could not

    be considered.

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  • Risk-based regulation thus designates a heterogeneous package of

    assumptions and practices that, while mutually reinforcing, do not inher-

    ently or logically require each other. Opening up risk as a heterogeneous

    construct rather than a logical system is important for contemplating inter-

    ventions into the WTO risk framework and adjudication process.

    The EC Biotech Decision

    Some of these issues were quite prominently dealt with in the recent WTO

    dispute pitting the United States, Canada, and Argentina against the EC

    over trade in GM products. The dispute to be settled was the European

    Unions (EUs) policy of trade restrictions on bioengineered food and

    agricultural products (GM foods). The United States claimed that

    Since October 1998, the European Communities (EC) has applied a morator-

    ium on the approval of products of agricultural biotechnology (biotech

    products). Pursuant to the moratorium, the EC has suspended consideration

    of applications for, or granting of, approval of biotech products under the EC

    approval system. In particular, the EC has blocked in the approval process

    under EC legislation all applications for placing biotech products on the mar-

    ket, and has not considered any application for final approval. The approvals

    moratorium has restricted imports of agricultural and food products from the

    United States. (WTO 2003a)

    The United States also cited particular EU country safeguard measures

    essentially temporary bansplaced on products that had already been

    approved by the EC before the moratorium was imposed.

    In its decision, the dispute resolution panel ruled largely in favor of the

    complaining parties (WTO 2006). The panels ruling that the EC morator-

    ium was illegal rested on two lines of argument: (1) the EC did institute a de

    facto moratorium that resulted from non-transparent regulatory procedures

    and led to an undue delay of decision making for specific products; and

    (2) EC member state safeguard measures were applied in a trade-illegal way

    because they were not based on risk assessmentsas made clear by a

    close reading of the legal documents surrounding these measures. Transpar-

    ency of regulatory procedures, avoiding undue delay in decision making,

    and risk-based assessments are all requirements of the SPS agreement.

    The ruling was largely procedural in its logic, focusing on decision-

    making procedures rather than the content of the decisions themselves. In

    ruling on the moratorium, the panel focused on procedures for establishing

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  • the moratorium and the timeframe of various regulatory body meetings

    rather than the content of meetings or discussions. For the member country

    safeguard measures, the panel focused on the explicit lack of reference to

    quantitative risk assessment in decision-making documents. In one

    instance, that of an Austrian ban on T25 Maize, the panel suggested that the

    mere fact that a risk assessment had previously been performed by the EC

    suggested that a risk assessment could be performed and used in the

    decision making of member states, and thus the decision could not fit within

    the SPS 5.7 exemption which allows temporary measures under conditions

    of scientific insufficiency. In this instance, the procedural approach of the

    panel reduces risk assessment from a context specific to a universal and

    objective procedure.

    Codex Standards on Risk

    One avenue for intervening into the constructions of risk used in theWTO is

    through the Codex Alimentarius (Codex) Commission. The Codex Com-

    mission is the organization charged with developing the Codex

    Alimentarius, the International Food Code. Established in 1962 as a joint

    commission of the Food and Agriculture Organization and the World

    Health Organization, the Codex Commission has a dual mission to protect

    human health and to facilitate fair trade (Codex 2005a, Article 1 and page

    31). It emerged out of concerns over the unregulated proliferation of food

    additives worldwide. The commission is structured to work through scien-

    tific assessment and consensus to produce a more standardized food system,

    particularly related to food hygiene and labeling. Codex currently consists

    of both 237 vertical (commodity specific) standardspackaging and

    processing standards for such things as frozen fruit or milk7and numerous

    horizontal (practice specific) standardsincluding 37 standards on

    hygienic and manufacturing practices and 3,700 maximum limits for

    pesticide residues allowed in food (Codex 2006).

    Standards bodies such as Codex have become increasingly important in

    both environmental and trade regimes in recent years. In particular, the

    WTO contains language that strongly favors trade decisions based on inter-

    national standards (WTO SPS 1994, Article 3, as clarified by Annex A.3),

    specifically naming Codex and 4 other international standards bodies as

    producers of recognized (i.e., scientifically valid) standards that could legit-

    imate exceptions to free-trade rules. Thus, while Codex is a strictly volun-

    tary organization, its adoption by the WTO in 1994 has elevated its legal

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  • status considerably, thereby turning Codex into a heated battle ground for

    struggles over risk.8

    Historically, Codex standards were relatively narrow in scope, dealing

    with one product or procedure at a time. In the past decade, however, the

    Codex has attempted to articulate meta-standards for classes of food and

    regulatory procedures. For example, Codexs recently issued guidelines for

    dietary supplements, overcoming a stalemate on the issue reaching back to

    the early 1990s, suggest that such supplements should be regulated based on

    risk analysis rather than customary or traditional knowledge and practice

    (Codex 2005b).9

    In 2003, Codex published a set of procedures and principles relating to

    risk analysis, generally, and risk analysis for foods derived from modern

    biotechnology, more specifically. These documents were the outcome of

    a protracted negotiation over six years (Poli 2004, 620).

    The principles state that all new biotech-derived products should

    undergo a premarket safety assessment that identifies potential hazards and

    differences in nutrient content compared to the conventional counterpart.

    Risk assessment should then determine the magnitude and relevance of such

    modifications for human health; risk management strategies should be

    developed to ensure safe standards, accounting for existing uncertainties;

    and risk communication should be used to ensure an open and consensual

    process. The burden of proof thus rests with the manufacturer, but it is a bur-

    den that relies on substantial equivalence doctrines, as discussed above,

    with their tendency toward affirmative risk requirements (although, see

    Levidow, Murphy, and Carr 2007 for the changing meaning of substantial

    equivalence within Codex).

    It is still an open question as to what impact Codex risk documents will

    have for WTO adjudication, particularly around GMOs. A number of fea-

    tures of Codex and the Codex/WTO relation suggest tensions in Codexs

    role, as either challenging or shoring up WTO procedures.

    First, it remains unclear whether the Codex policy on risk analysis is an

    internal procedure for deriving standards or whether this procedure has rele-

    vance for WTO adjudication (Veggeland and Borgen 2005, 695). The gen-

    eric Working Principles for Risk Analysis was incorporated into the

    commissions Procedural Manual, rather than published as a standard

    (Codex 2005a,b, sec. III). However, SPS defers to Codex, not just for stan-

    dards but for international standards, guidelines or recommendations.

    This may suggest, but not clearly, that any approved Codex procedure

    serves as a precedent for the WTO. The distinction between procedures and

    standards is not merely semantic but raises a central question about the

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  • status of Codex within the WTO. Do Codex decisions have credibility and

    thus command deference because they are presumed to be technically accu-

    rate, or is Codex understood to be an effective venue for establishing polit-

    ical consensus around technical issues? The literature on standards suggests

    that the latter function is historically dominant: precise, reproducible, and

    stable measures are preferable to increasingly accurate ones (Porter 1995,

    29). The quandary here is that the risk standards are essentially meta-

    standards, that is standards for neither food products nor production pro-

    cesses but rather for regulatory processesa role that seems to stretch the

    vision of Codex in the SPS agreement, which treats Codex as a technical

    rather than political and regulatory agency.10

    Second, the Codex standards explicitly articulate definitions of and rela-

    tions between risk analysis, risk assessment, risk management, and risk

    communication. These terms and their relations are highly contested and

    fraught with political implications, even within WTO adjudication. For

    example, in EC Beef (Hormone), a well-known case dealing with risk anal-

    ysis under SPS, the Appellate body rebuked a dispute resolution panel for

    attempting to distinguish between risk assessment (as science) and risk

    management (as policy) when there was no clear textual directive in WTO

    documents to do so: The fundamental rule of treaty interpretation requires

    a treaty interpreter to read and interpret the words actually used by the

    agreement under examination and not words which the interpreter may feel

    should have been used (WTO 1998, para.181). The risk analysis proce-

    dures laid out in Codex, however, also make a distinction between risk

    assessment and risk management. This suggests that such a distinction may

    prevail in future cases, tending toward a narrower reading of the WTO call

    for risk assessment. However, Codex also makes clear that risk assessment

    itself is insufficient to regulate risks, and a meaningful policy necessarily

    includes the broader factors available to risk management and risk commu-

    nication. Thus, resolution panels are potentially faced with the quandary of

    reading WTO as providing a textual directive to use narrowly construed sci-

    entific risk analysis while Codex standards provide a textual directive to

    incorporate risk management and communication.

    Third, Codex gives a particular meaning to the notion of sound sci-

    ence. This is a politically charged term in regulation and risk analysis,

    often used to support the risk-based approach to policy making, against pre-

    caution. The Principles for Foods Derived from Biotechnology define

    sound science as being of a quality and, as appropriate, of quantity that

    would withstand scientific peer review (Codex 2003, 2). Theorists of pre-

    caution and science-based policy making have specifically addressed this

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  • formulation as hampering regulatory action in the face of uncertainty or

    suggestive information (Jasanoff 1990; Thornton 2000), particularly in the

    context of the WTO which requires affirmative evidence to regulate,

    although it may also open the doors to 5.7 exceptions by allowing the articu-

    lation of scientific insufficiency. This standard thus seems to weaken earlier

    moves toward precaution within Codex.

    Fourth, and in tension with the previous point, Codex potentially opens a

    space for including a multitude of non-scientific factors in risk management

    decisions. Codex standards are conscious human constructs, which rely on

    facts of nature (are science based), but are not inherent in them. A range

    of human considerations, therefore, may be relevant to the negotiation of a

    standard. The classic examples here are kosher, halal, and organic stan-

    dards. These are not natural, but rather historical, cultural, and marketing

    categories, as we can see in this assertion from the Codex organic standards,

    which combines human health, environmental, economic, and cultural con-

    siderations: the primary goal of organic agriculture is to optimize the

    health and productivity of interdependent communities of soil life, plants,

    animals and people (Codex 1999, 2). It is here that the second side of

    Codexs double charge becomes centralfair trade. Fair trade, in contrast

    to free trade, is dedicated to stability and information in the market-

    placethat is, standardizing categories and meanings such that consumers

    have predictable products. Whereas the WTO favors the establishment of

    equivalence among diverse products and regulatory approaches (harmoni-

    zation), based on purified scientific assessment, Codex favors uniformity

    and consensus (standardization), which may incorporate both scientific and

    cultural assessments (see WTO SPS 1994, Article 4).11

    Related to this, the goal of fair trade favors information provision about

    products themselves in the form of standardized and clearly used labels.

    Although Codex labeling standards may support and reinforce nondiscrimi-

    nation, as required by the WTO, they may also (1) include nonhealth related

    factors and thus may provide a way to bypass stricter SPS requirements; and

    (2) emphasize product uniformity rather than health-based equivalence, and

    thus allow differentiation where a strictly scientific risk assessment may

    not find one. These approaches run counter to a narrow interpretation of

    WTO rules.

    Finally, Codex provides a very different institutional context than the

    WTO in which to negotiate controversial issues. Codex increasingly

    emphasizes the inclusion of a range of affected parties in decision making,

    transparency, consensual standards, and the clear communication of all sci-

    entific and nonscientific assessments and may therefore be more politically

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  • open than the WTO, which favors closed decision-making panels. This

    potential for transparency and inclusiveness, however, only exists to the

    extent that a broad range of affected parties increasingly recognize technical

    bodies such as Codex to be deeply political sites for intervention. This is

    already happening among advocacy groups, but Codex remains largely

    under the political radar.12 And it may already be rather late in the game for

    risk standards in particular, as they have already been worked out and pub-

    lished. Although Codex clearly allows revisiting and modifying standards,

    Codex standards (as is true for all standards) become quite difficult to mod-

    ify significantly once established.

    Cartagena and Precaution

    The CBP serves as a model for a very different sort of intervention into

    international trade regimes. Although to date its influence on the major con-

    troversies has proven relatively minor, it affords the opportunity to look at

    the complex relations between regimes, and also brings trade/environment

    conflicts into particularly stark focus.

    The CBP regulates international (transboundary) movement of a signif-

    icant subset of bioengineered products designated LMOs. Whereas the

    WTO covers trade, in general, the CBP is very narrowly focused on trade

    of these LMOs. The CBP is actually a subsection of the Convention on Bio-

    diversity, which was negotiated at the 1992 Rio Conference. After a failed

    attempt to reach consensus in Cartagena, Colombia in 1999, the CBP was

    eventually finalized and signed in Montreal on January 29, 2000. The CBP

    came into force September 11, 2003, but without U.S. ratification.13

    The CBP establishes a duty by countries exporting LMOs to garner

    advance informed consent from the importing country. To do this, the

    exporting country must submit a request for approval, provide risk and other

    scientific data if requested, and wait for a response before beginning ship-

    ments. It gives the importing country freedom to regulate (allow or disal-

    low) such imports based on sovereign standards of risk and to label or

    not label them for internal markets as the country sees fit.

    The CBP was negotiated with the WTO specifically in mind, but partly

    because it was part of an environmental rather than a trade agreement,

    partly because of the specific politics surrounding GM products, and partly

    because of the internal dynamics of priorities and tradeoffs during negotia-

    tion (see Gupta 2000), the relation of the CBP to WTO was left somewhat

    ambiguous. This ambiguity is evident in the preamble, which contains the

    following text:

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  • Recognizing that trade and environment agreements should be mutually

    supportive with a view to achieving sustainable development,

    Emphasizing that this Protocol shall not be interpreted as implying a

    change in the rights and obligations of a Party under any existing international

    agreements,

    Understanding that the above recital is not intended to subordinate this

    Protocol to other international agreements, . . . .

    The second clause here, a classic savings clause (Safrin 2002), suggests

    deference to free-trade agreements, but the third seemingly reverses that.

    The first clause, I suggest, hints toward the legal approach for resolution via

    harmonization.14

    Such harmonization turns out to be conceptually difficult because the

    CBP, following the Rio Declaration more broadly, is precautionary. Again,

    while precaution implies a particular orientation toward uncertainty, it also

    designates a broader framing of science, risk, burden of proof, and exper-

    tise, which runs in many ways counter to the WTOs risk framework. The

    protocol not only invokes the precautionary principle explicitly (in accor-

    dance with the precautionary approach contained in Principle 15 of the Rio

    Declaration on Environment and Development, the objective of this

    Protocol is to contribute to ensuring an adequate level of protection in the

    field . . . (Article 1)) but also lays out the particular import of thisprinciple for regulation, in Article 10 (sec. 6):

    Lack of scientific certainty due to insufficient relevant scientific information

    and knowledge regarding the extent of the potential adverse effects of a living

    modified organism on the conservation and sustainable use of biological

    diversity in the Party of import, taking also into account risks to human

    health, shall not prevent that Party from taking a decision, as appropriate,

    with regard to the import of the living modified organism in question as

    referred to in paragraph 3 above, in order to avoid or minimize such potential

    adverse effects.

    Thus, in cases of uncertain risk, countries are at liberty to regulate the

    import and sale of LMOs. This seems to be at odds with the WTO, as con-

    ventionally understood.15 This freedom to regulate under uncertainty sug-

    gests the other crucial aspect of precautiona reverse onus of proof.

    Proof of safety rather than proof of harm underlies the protocol. The onus

    rests on the exporting country to initiate the process, convince the importing

    country of safety, and conduct follow-up testing if the importing country

    requires it. Although the presumption of free trade from theWTO still exists

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  • as a shadow in this document, it has essentially been reduced to a less

    compelling norm of free trade for LMOs. Thus, the CBP allows the follow-

    ing statement, which would be unheard of in the WTO agreements: A fail-

    ure by the Party of import to communicate its decision within two hundred

    and seventy days of the date of receipt of the notification shall not imply its

    consent to an intentional transboundary movement (Article 10, sec. 5). In

    other words, the presumption appears to be one of restriction rather than

    free trade.

    Equally important here is that, while the text of the CBP specifies that

    The Party of import shall ensure that risk assessments are carried out for

    decisions taken under Article 10 (Article 15, sec. 2) and that Risk assess-

    ments undertaken pursuant to this Protocol shall be carried out in a scienti-

    fically sound manner (Article 15, sec. 1), it also suggests

    The Parties, . . . may take into account, consistent with their international

    obligations, socio-economic considerations arising from the impact of living

    modified organisms on the conservation and sustainable use of biological

    diversity, especially with regard to the value of biological diversity to indi-

    genous and local communities. (Article 26, sec. 1).

    Although this consideration of socioeconomic factors is not completely

    open-ended, here is a mixing of physical and socioeconomic risks to human

    health, the environment, and indigenous and local communitieswhich

    are often equated with biodiversity (Article 26, sec. 2; see also discussion by

    Stabinsky, 2000, on inclusion of socioeconomic assessment in the CBP).

    This mixing of concerns not only has the potential to shift the basis of deci-

    sion making but also opens up the range of experts involved, thus raising the

    potential for national and transnational political movements to achieve

    some standing in the decision-making process.

    Finally, and closely related to the precautionary stance, the Cartagena

    protocol is essentially an informational protocol which compels interna-

    tional labeling of LMOs. Here, then, is another central tension with the

    WTO. Whereas the technical barriers to trade of the WTO acts against

    labels as TBT, unless supported by affirmative scientific evidence of

    harm, the CBP sets in place a requirement to label, regardless of potential

    harm, in such a way that the receiving country can regulate based on essen-

    tially sovereign criteria. Thus, while the WTO works from a substantial

    equivalence doctrine requiring prima facie evidence to even raise the

    possibilities of labels, CBP works from a consumer choice framework in

    which information is always desirable. In the details, these two regimes are

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  • not quite so obviously at odds, however, as the WTO deals primarily with

    labels geared toward individual consumers, whereas the CBP labels are

    geared toward the state. In practice, however, this distinction may not

    always hold up as guaranteeing label integrity and product segregation may

    compel item-level labeling in many instances, and it is unlikely that state

    actors will literally intercede to remove labels before sale.

    This precautionary stance toward GM food regulation is mirrored in

    European policy. Again, the rBST case serves as a clear example. Whereas

    United States approved rBST use in dairy cattle in 1993, the EU still has a

    moratorium in effect on its use. Concerns cited in the policy included the

    uncertainties associated with increased IGF-1 production, subtle molecular

    difference with the hormone itself, and issues of bovine health,16 but of

    greatest significance was the devastating effect that this and related technol-

    ogies were likely to have on small European dairy farms (Gottweis 1998).

    Precaution, then, related not just to human health but to wider concerns with

    social, cultural, and economic risk.

    In all of these details, the WTO closely mirrors the approach taken by the

    United States toward GM food regulation, and the CBP closely mirrors the

    EUs recent approach, and the relation between these two protocols is left

    somewhat ambiguous.

    Institutional Conflict

    Resolving Relations Between the Regimes

    The question remains as to how much of an opportunity the tensions

    between and within these three regimes provide for transforming WTO

    adjudication to allow for a broader range of perspectives and voices, accept

    precautionary reasoning, provide space for arguments about justice, or oth-

    erwise moderate the universalistic, expert-driven risk framework.

    Although a connection between the WTO and the Codex is solidified in

    the text of the SPS agreement itself, the same cannot be said for the CBP. It

    remains an open question as to whether this regime will have any affect at

    all on future WTO adjudication. Part of that question will reside in the ways

    that WTO panels interpret specific provisions of this regime and interna-

    tional law, and the WTOs relation to both of these.

    Priority in international law is more difficult to resolve than in domestic

    legal settings. The Vienna Convention on the Law of Treaties sets rules for

    establishing priority and guiding interpretation of treaties. This convention

    states that the date of signature is the basis for resolving such disputes: the

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  • later protocol supersedes the earlier, unless otherwise specified in the latter

    treaty itself. However, this can be rather difficult to settle in a continuously

    modified, living document such as the WTO. Does the addition of a new

    agreement or renegotiation of an old one recommit the member states to the

    entire body of law, or only to the specific text of that agreement? The

    answer to such questions is not clear (see Pauwelyn 2001). Furthermore,

    most treaties state that new obligations do not supersede or negate previous

    ones, so treaty conflicts are often internalized within each agreement itself.

    This is clearly the intent of the CBP savings clause, as mentioned above,

    but it is moderated by surrounding text. This problem is reinforced by Arti-

    cle 31(3)(c) of the Vienna Convention, which states the broader principle

    that previous obligations and international laws should inform treaty inter-

    pretation (Howse 2002a).

    Furthermore, the forum for resolution can also play a significant role in

    resolving priority. That is, WTO dispute resolution panels are committed to

    upholding the structure under which they are empanelled. To what extent

    are they empowered to disregard those rules in favor of law from an entirely

    different area of concern, or vice versa, to what extent can they legitimately

    ignore other bodies of international law? Panels are usually expected to

    uphold all international obligations (Safrin 2002), but it is not clear that this

    is always possible.

    At the present, perhaps the most important aspect of working out rela-

    tions between the CBP and the WTO is to recognize that the major GMO

    producing nations have not actually ratified the CBP, although they were

    quite active in negotiating it.17 The WTO dispute resolution panel for the

    EC Biotech case, therefore, very quickly dismissed any need to take account

    of this protocol or the precautionary framework it supports. Since none of

    the challenging parties had in fact ratified the CPB, its mandates and lan-

    guage were irrelevant to this dispute. In addition, while it could be used

    to make sense of terms like precaution, it had no statutory value for this

    dispute as either an agreement or as a normative prescription. In other

    words, until both parties in a dispute ratify a regime it can have no direct

    bearing on the resolution of that dispute.

    Unless and until some of the major GM producing states sign the CBP, it is

    unlikely that this regime will ever have more than a minor institutional effect.

    Toward Institutional Harmonization?

    Although priority issues may be the most obvious way to resolve the

    relations between competing regimes, framing compatible interpretations

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  • between theminterpretations that takes seriously the actual textual basis

    of both frameworksseems more likely over the long term. The ideal of

    codifying a unified and coherent body of international law, as opposed to

    competing sets of ad-hoc frameworks, occupies considerable space in legal

    and academic journals on international law (e.g., Pauwelyn 2001; Howse

    2002a). In the context of WTO adjudication, this integration is already

    taking place through the interpretation of terms like risk, precaution, and

    sound science, which have textual basis in multiple regimes, as well as in

    the increasingly integrated politics of product standardization in institutions

    such as Codex.

    These two processes, conceptual harmonization on one hand and the pro-

    duction of standards on the other, suggest both opportunities and dangers

    for those seeking justice-based interventions in WTO adjudication. The first

    is being driven within the WTO by the ascension over the past decade of

    international legalists, who strongly favor harmonization in international

    law, over narrow free-trade ideologuesin Howses (2002b) phrase, a

    trade policy elite (this argument is developed further in Halfon

    2006b). From this perspective, whether theWTO does eventually accept the

    CBP as relevant in particular cases, the dispute over priority is likely to be

    resolved by harmonizing frameworks, rather than simply ruling one regime

    as prior to the other. And in the interim, while the CBP does not provide an

    immediate and direct opening to WTO adjudication, it helps frame some

    challenges, and some potential resolutions, that may find their way into

    WTO adjudication through this impulse to harmonize. For example, the

    CBPs alternative vision for trade relations based on precaution uses

    language similar to that found in the WTO and conceptually open to a

    risk-based interpretation of precaution. Thus, while risk and precaution are

    historically antagonisticembodying deep conflicts of world view requir-

    ing macro-political resolutiona move away from risk and precaution as

    logical frameworks, and toward an understanding of them as historical

    packages of practices and assumptions about science, risk, uncertainty, and

    expertise, along with the similar textual language of the WTO and CBP,

    suggest that these frames may be harmonized on an ongoing basis in the

    micropolitics of institutional practice. This reinterpretation of basic con-

    cepts may be a difficult but promising way forward for activists and others

    concerned with social or economic justice.

    Although the CBP holds out the discursive possibility of intervention

    through conceptual harmonization, the structural integration of Codex and

    other standards agencies into the WTO provides a clearer pathway to such

    an outcome. Standards agencies are a potentially more powerful but more

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  • fraught approach to these goals. Whereas harmonization implies an articu-

    lation of equivalencies across diversity, standards rely on the idealized

    equalities of exactitude (Barry 2001). Harmonization in its postmodern

    sense of equality amidst diversity produces what I have called a structured

    disunity (Halfon 2006a)sets of equivalencies that function as if they

    were the samethus always maintaining the possibility of subversion and

    rearticulation. Standards, however, form a powerful vestige of modern-

    ism in their quest for specificity, immutability, and mobility (Porter

    1995; Timmermans and Berg 2003, 8).

    Thus, we can see both promise and danger in recent Codex risk stan-

    dards. Codex articulates an explicit reformulation of the risk-precaution

    divide, in the form of precautionary risk analysis: Precaution is an inherent

    element of risk analysis (Codex Procedural Manual, 43). This formulation

    provides a textual resource for the WTO to work out an interpretation of the

    precautionary principle that maintains a procedural requirement of risk

    assessment amidst the substantive claim of precaution.18 If risk gets

    widened to incorporate some social dimensions, and converted into a

    procedural requirement, and precaution gets narrowed into a risk-based

    framework, we may see a slow convergence of these principles in interna-

    tional trade law. Such a configuration holds promise for a more open

    decision-making system, but at the risk of increasing managerialism and

    scientific positivism, which might leave little room for the very justice

    issues that activists seek to address.

    Notes1. For example, and of particular interest to readers of this journal, three Amicus

    Curiae briefs submitted to the WTO adjudication panel on the US-EC GMO dis-

    pute, including one by a group of STS and law scholars, were accepted into the

    record by the panel but were not used in the course of deliberation, and based on

    the discussion in paragraphs 7.10-11, clearly had no effect on the outcome. See

    Winickoff et al. (2005) and WTO (2006). On the broader trend of opening inter-

    national institutions to nonstate actors, see Keck and Sikkink (1998).

    2. And even then, the barriers put in place are considered provisional and require

    resolution of the underlying uncertainty within a reasonable period of time

    (WTO SPS, Article 5, sec. 7).

    3. These frameworks, as heterogeneous constructions rather than logical categories,

    are subject to a number of imperfectly descriptive, and often highly politicized,

    names. The risk framework is also called the sound science approach which

    emphasizes its reliance on positivistic science (Gupta 2000; Levidow and Carr

    2000). The precautionary framework has also been interpreted to be a specific

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  • principle of an ecological approach (Thornton 2000) or ecological moder-

    nization (Hajer 1993), which emphasize the broader political and cultural

    dynamics of these debates.

    4. The EC Biotech panel, following an earlier appellate decision, actually left room

    for product destruction by pestsa form of economic rather than environmental

    riskas a legitimate reason for an SPS measure (see WTO 2006, 7.2575-77).

    5. Schwarz and Thompson (1990) challenge conventional views of uncertainty in

    science policy which treat uncertainty as an explanatory variable. Instead, they

    suggest, uncertainty often designates the competing certainties that arise from

    deeper cultural conflicts.

    6. For insight into the use and controversy over the term substantial equivalence

    in regulation, see Millstone, Brunner, and Mayer (1999), Miller (1999),

    Schenkelaars (2002), and Levidow, Murphy, and Carr (2007).

    7. For example, frozen strawberry standards specify requirements for the process-

    ing and packaging of frozen strawberries, delineating what can and cannot be

    included in such packages, sanitary measures that must be taken, required prop-

    erties of the packaging material, and what certain labeling claims must desig-

    nate (i.e., large whole free-flowing strawberries has a very specific

    meaning).

    8. On the complexity of the relation between the WTO and the Codex, see Howse

    (2002a, 250-2).

    9. For some commentary on the dispute over these guidelines, see National Health

    Federation Web site at http://www.thenhf.com/codex_21.htm; the US FDA

    Web site at http://www.cfsan.fda.gov/*dms/dscodex.html; and the WestonA. Price Foundation Web site at http://www.westonaprice.org/federalupdate/

    aa2005/infoalert_072705.html

    10. Complicating this further, more specific guidelines on the application of risk

    analysis to particular commodities, including foods derived from modern bio-

    technology are listed in Codex documents as standards.

    11. In this context, accidents of the standards process may have profound effects.

    This can be seen in the WTO Sardines case, which used Codexs broad use

    of the category sardines as a generic class of packaged fish to rule against

    the ECs narrower interpretation of sardines as a regionally specific product.

    12. See the impressive work of Public Citizen, in particular, in understanding the

    importance of Codex to international food policy.

    13. United States was one of a small group of countries that attempted to have these

    issues discussed at the infamous Seattle WTO talks rather than under the rubric

    of the Convention on Biodiversity.

    14. Safrin (2002) suggests that a consistent legal reading of the CBP preamble

    requires such a mutually supportive approach since tribunals are loath to

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  • interpret treaty provisions in such a way that they extinguish each other, let

    alone produce the opposite result of what the treaty plainly states (620-1).

    15. Although, uncertainty here is couched in the language of scientific insufficiency

    and may thus be interpreted in a way that is directly compatible with the SPS

    Article 5.7 exception discussed above.

    16. More recent studies in Canada strongly underscored such concerns with bovine

    health. See Health Canada (1998).

    17. As a nonsignatory of the Convention on Biodiversity, the United States is cur-

    rently barred from joining the CBP (Gupta 2000).

    18. Bohanes (2002) calls explicitly for such an approach as a way to resolve the

    antidemocratic and antisovereign tendencies of the WTO. See also Halfon

    (2006b).

    Acknowledgments

    I would like to thank Steve Yearley, Eugenia Rodrigues, Joao Arriscado

    Nunes, Helena Machado, and Anabela Carvalho, and attendees at the Scien-

    tific Proofs and International Justice workshops in Braga and Coimbra,

    Portugal, 2005, for comments on a much earlier version of this article. I also

    thank journal editor Geof Bowker and 3 anonymous reviewers for helpful

    comments on this version.

    Declaration of Conflicting Interests

    The authors declared no conflicts of interest with respect to the authorship

    and/or publication of this article.

    Funding

    The author received no financial support for the research and/or authorship

    of this article.

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    WT/DS291/R.

    Wynne, B. 2001. Creating public alienation: expert cultures of risk and ethics on

    GMOs. Science as Culture 10 (4):445-81.

    Bio

    Saul Halfon, an associate professor of Science and Technology Studies at Virginia

    Tech, works in the political sociology of technoscience. His 2006 book, The Cairo

    Consensus: Demographic Surveys, Womens Empowerment, and Regime Change in

    Population Policy, is available from Lexington Books.

    Halfon 329

    329

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